Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Registration Number
- NCT06408259
- Lead Sponsor
- Celgene
- Brief Summary
The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 194
-
Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.
-
Meets at least 1 of the following criteria for disease activity:
i) At least 1 MS relapse/attack in the previous year prior to screening.
ii) At least 2 MS relapses/attacks in the previous 2 years prior to screening.
iii) Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI).
- Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive.
- Diagnosis of progressive forms of MS.
- Active or chronic disease of the immune system other than MS.
- Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fingolimod Placebo - Fingolimod Fingolimod - Ozanimod Ozanimod - Ozanimod Placebo -
- Primary Outcome Measures
Name Time Method Annualized relapse rate (ARR) Up to 2 years
- Secondary Outcome Measures
Name Time Method Proportion of participants who did not have a confirmed relapse At 12 and 24 months Incidence of treatment-emergent adverse events (TEAEs) over the treatment period and over the post-treatment follow-up period Up to 87 months Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period Up to 87 months Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences At 6, 12, 18, and 24 months Steady state plasma concentrations of ozanimod At day 90 Steady state plasma concentrations of the primary active metabolite CC112273 At day 90 Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count At day 90 and throughout the study up to 24 months Number of gadolinium enhancing (GdE) T1 lesions At month 6 and month 12 Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period Up to 87 months
Trial Locations
- Locations (31)
Local Institution - 0110
๐บ๐ธPhoenix, Arizona, United States
Local Institution - 0114
๐บ๐ธLoma Linda, California, United States
Local Institution - 0053
๐บ๐ธTampa, Florida, United States
Local Institution - 0093
๐บ๐ธChicago, Illinois, United States
Local Institution - 0055
๐บ๐ธChicago, Illinois, United States
Local Institution - 0091
๐บ๐ธCincinnati, Ohio, United States
Local Institution - 0092
๐บ๐ธPortland, Oregon, United States
Local Institution - 0033
๐บ๐ธMilwaukee, Wisconsin, United States
Local Institution - 0113
๐ฆ๐บMelbourne, Victoria, Australia
2Ca Braga
๐ต๐นBraga, Portugal
Local Institution - 0105
๐ต๐นCoimbra, Portugal
Local Institution - 0104
๐ต๐นLisboa, Portugal
Local Institution - 0102
๐ต๐นPorto, Portugal
Local Institution - 0096
๐ช๐ธEsplugues de Llobregat, Barcelona [Barcelona], Spain
Local Institution - 0098
๐ช๐ธVigo, Pontevedra [Pontevedra], Spain
Hospital Universitario Virgen Macarena
๐ช๐ธSevilla, Spain
Hospital Universitari i Politecnic La Fe
๐ช๐ธValรจncia, Spain
Local Institution - 0130
๐บ๐ธSacramento, California, United States
UCSF Benioff Children's Hospital San Francisco
๐บ๐ธSan Francisco, California, United States
Axiom Clinical Research of Florida
๐บ๐ธTampa, Florida, United States
Washington University
๐บ๐ธSaint Louis, Missouri, United States
University of Naples Federico II
๐ฎ๐นNapoli, Campania, Italy
Ospedale San Raffaele
๐ฎ๐นMilano, Lombardia, Italy
Neurological Center Of Latium
๐ฎ๐นRome, Roma, Italy
Local Institution - 0078
๐ฒ๐ฝMexico City, DIF, Mexico
Uniwersytecki Szpital Kliniczny w Poznaniu
๐ต๐ฑPoznaล, Wielkopolskie, Poland
Local Institution - 0088
๐ท๐ดBucharest, Bucureศti, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
๐ท๐ดBucharest, Bucureศti, Romania
Local Institution - 0101
๐ช๐ธZaragoza, Spain
National Taiwan University Hospital
๐จ๐ณTaipei, Taiwan
Local Institution - 0109
๐น๐ทSamsun, Turkey